|Anthrax Vaccines Not Harmful to Women's Reproductive System, Studies Shows |
Anthrax Vaccines Not Harmful to Women's Reproductive System, Studies Shows
By Harry Noyes, Army News Service.
Fort Sam Houston, Texas -- (ANS) September 28, 2001 -- A study conducted by an Army preventive-medicine officer has calmed concerns that anthrax vaccinations might damage the reproductive success of military women.
Maj. Andrew R. Wiesen tracked the health of 4,092 active-duty service women. Out of that number, 513 women became pregnant during the course of the 15-month study, including 384 women who had been vaccinated against anthrax.
Compared to unvaccinated women, the vaccinated soldiers were just as likely to get pregnant and just as likely to give birth to healthy babies, Wiesen studies indicated. Birth problems and defects were no more frequent for the vaccinated moms than for others.
The study was conducted at Fort Stewart, Ga. All of the women in the study were stationed at Fort Stewart or nearby Hunter Army Airfield.
"Pregnancy is an outcome that is almost never studied with vaccination, given the inherent difficulties in studies of that nature," Wiesen said. "We were just very fortunate to have a set of databases that allowed us to get the information we needed when we needed it."
Wiesen was chief of preventive medicine at Fort Stewart's Winn Army Community Hospital during the study, which ended in March 2000. He has since transferred to Madigan Army Medical Center, Fort Lewis, Wash., as chief of epidemiology.
Wiesen initiated and conducted the study on his own, but his protocol was reviewed and approved by the Institutional Review Board of the department of clinical investigation at Southeast Regional Medical Command. He was assisted by Capt. Christopher Littell, a pediatrician who served as a subject matter expert on adverse birth outcomes.
Wiesen reported on the preliminary study results to a committee of the Institute of Medicine in July. He acknowledged that a larger study might reveal more, but that this one strongly indicates that there are no reproductive health problems associated with vaccination of military women.
"It is impossible to prove a negative, i.e., it cannot be proven that anthrax vaccine does not cause any harm," Wiesen explained. "The major benefit of negative studies such as this one -- studies that do not show a relationship between the exposure of interest and an outcome -- is that it increases our confidence that there is not a relationship.
"These types of studies are always subject to criticism that they should have been bigger, or a small effect could have been overlooked, etc. However, the likelihood of that occurring in this case is very small."
Wiesen's report on the research is being peer-reviewed for use in a major medical journal and should be published before the end of the year.
(Editor's note: Harry Noyes is a member of the public affairs team for the Army's Medical Command at Fort Sam Houston, Texas.)